Adjustable knee brace

ABSTRACT

A knee brace with an articulation assembly connectable with a first cuff movable with respect to the articulation assembly about a first location defining a first pivot axis between the first cuff and articulation assembly, and movable about a second location defining a first rotation axis between the first cuff and articulation assembly. The knee brace may have a second cuff connectable with the articulation assembly and movable with respect to the articulation assembly about a third location defining a second pivot axis between the second cuff and articulation assembly. The second cuff is movable about a fourth location defining a second rotation axis between the second cuff and articulation assembly. The first pivot axis and first rotation axis may intersect each other or be offset from intersecting each other, the second pivot axis and second rotation axis may intersect each other or be offset from intersecting.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of and claims priority to U.S.patent application Ser. No. 15/943,869, filed Apr. 3, 2018 and titled“ADJUSTABLE KNEE BRACE,” which is incorporated herein by reference inits entirety.

FIELD OF THE INVENTION

The present invention is directed to a knee brace having improveddesign, construction, functional and aesthetic features.

BACKGROUND OF THE INVENTION

A human knee joint is comprised of three compartments: 1) suprapatellarpouch and patellofemoral joint (includes the patella, patellofemoraljoint, the trochlear notch of the femur, and synovial plicae); 2) medial(includes the medial femoral condyle, the medial tibia plateau, and themedial meniscus); and 3) lateral (includes the lateral femoral condyle,the lateral tibial plateau, and the lateral meniscus). Although acomplicated joint, the various compartments and components of a healthyknee joint simply need to isolate the femur and tibia bones fromcontacting each other, and facilitate smooth movement between them. Tothis end, articular cartilage on the medial and lateral condyles of thefemur, and on the tibial plateau, together with medial and lateralmeniscus, serve to isolate the femur and tibia bones from each other.

A properly functioning knee joint relies heavily on the condition of thecartilage and meniscus. Degradation of these critical components resultsin functional degradation of the knee joint which, in turn, results inpain and discomfort, and possibly more limited mobility or immobility.Over time, the cartilage and/or meniscus may degrade and/or be damaged,resulting in a decrease in the isolative properties they are intended toprovide. For example, osteoarthritis is a degenerative disease that canaffect the knee joint, and that can result in wearing away of thearticular cartilage over time. This typically occurs in the medialcompartment sooner than in the other compartments, but multi- ortri-compartmental osteoarthritis is not uncommon. When the articularcartilage is damaged, degraded or no longer present on the femur, thatcan negatively affect the corresponding meniscus, and can ultimatelylead to painful direct bone-on-bone contact between the femur and tibia.

There are non-surgical, therapeutic ways to address this pathology ofthe knee that typically involve modifying or adjusting the biomechanicsof the knee joint. A knee brace can be used to effect this end. Kneebraces intended to address symptoms of osteoarthritis shift the user'sweight from the compartment with damaged cartilage to the compartmentwithout damaged cartilage. Osteoarthritis knee braces accomplish thisusing a condyle pad to apply pressure laterally to the medial or lateralsides of the knee, and by using rigid or semi-rigid cuffs and strapsthat are generally fixed on the thigh and calf to pull or exert pressureon the thigh or calf in the direction opposite that of the condyle pad.These forces are sometimes called three-point loading and can modify oradjust the static and dynamic biomechanics of the knee joint. Theintended effect of these forces is called unloading because thethree-point loading unloads one of the knee compartments to dynamicallychange the condition of the knee joint and reduce the pain anddiscomfort associated with osteoarthritis. By changing the alignment ofthe femur, knee joint and tibia, such braces can compartmentally alterthe amount of pressure experienced in the knee joint, e.g., by shiftingthe amount of pressure borne by one compartment to the other, forexample from the medial compartment (typically bearing the mostpressure), to the lateral compartment.

Some knee braces are intended to stabilize the knee joint or parts ofthe knee. For example, knee braces are provided that minimize lateraldisplacement of the knee joint in response to impact while allowing fornear-normal use of the knee. This type of knee brace may be worn byfootball players, for example. Some knee braces are intended toimmobilize or stabilize parts of the knee, such as the patella. Forexample, U.S. Pat. Nos. 5,554,105 and 5,797,864 (the entire contents foreach of these patents being hereby incorporated herein by reference) areeach directed to a knee brace that stabilizes the patella. These patentsdisclose structure intended to stabilize the patella with Y-shaped andU-shaped components that are held in place with a combination of rigidand non-rigid parts.

Knee braces intended to treat the symptoms of osteoarthritis may utilizea pad that is positioned near and in contact with the wearer's theknee—often referred to as a condyle pad because of its proximity to themedial and/or lateral condyle. This pad may be movable towards and awayfrom the knee to vary the pressure applied to the knee joint in aneffort to adjust and modify the static and dynamic condition of theknee. More specifically, the condyle pad is typically selectivelymoveable or adjustable towards and away from the knee to cause a changein the biomechanics of the knee joint. For example, it may be desirableto change the load-bearing characteristics of specific kneecompartments, such as in a knee experiencing degradation of the medialcompartment (without corresponding degradation of the lateralcompartment) from osteoarthritis, where it may be desirable to relievethe load borne by the medial compartment. A knee brace with anadjustable medial condyle pad enables a wearer to change the load borneby the medial compartment, and hopefully provide relief to the pain anddiscomfort associated with osteoarthritis. However, knee braces providedin accordance with the teachings of the prior art require significantspace between the knee brace and the knee to enable sufficient movementof the condyle pad. This results in knee braces that define, by theirstructural components, an envelope about the wearer's knee that issubstantially larger than that defined by the wearer's knee.

In knee braces having a movable condyle pad there are at least threeconfigurations. A first has a single point of movement for the condylepad enabling movement of the pad towards and away from the knee joint.This enables the wearer to adjust the amount of pressure imparted by thecondyle pad on the knee. In knee braces of this type, the condyle pad iscaused to move along a line generally parallel with an axis defined by arotation point of the knee brace, i.e., generally transverse to theknee. An exemplary patent teaching such a knee brace is U.S. Pat. No.6,413,232 B1, the entire contents of which are hereby incorporated byreference. This patent teaches a knee brace with a condyle padadjustable along an axis that is parallel and coaxial with a rotationaxis of the knee brace. Movement of the condyle pad is also along a linethat is perpendicular with a longitudinal axis of the knee brace. Thus,the angular relationship between the condyle pad and upper and lowercuffs is fixed.

A second configuration for knee braces with a movable condyle pad has atleast two points of connection for the condyle pad, such as is disclosedin U.S. Pat. No. 7,485,103 B2, the entire contents of which are herebyincorporated herein by reference. Separate adjustment of the top andbottom of the condyle pad is not possible with this configuration, andthe points of connection for the condyle pad may be generally parallelwith but are not coaxial with the rotation axis of the knee brace. Avariation of this configuration provides for two points of adjustment ofthe knee brace (see, e.g., U.S. Pat. Nos. 5,766,140 and 5,797,864, theentire contents of each of which is hereby incorporated herein byreference). These patents each teach two points of adjustment providedabove and below, and outside an envelope defined by, the condyle pad,see, e.g., FIG. 4 of the '140 patent. The embodiments disclosed in thispatent have two hinges 4, 4′ located above and below the knee joint andflexion hinge 24 (located at the knee joint). Adjustment screws 49 areprovided at each hinge for user adjustment of a condyle pad 26. Thispatent discloses embodiments comprising a single hinge 4, as well as twohinges 4, 4′, each embodiment locating the hinge away from the flexionhinge 24. A third configuration for knee braces with a movable condylepad has a pivot point of the condyle pad which provides for pivotabledisplacement of the condyle pad towards and away from the wearer's knee.

Exemplary prior art knee braces of this type can be found in U.S. Pat.Nos. 4,372,298, 4,940,045, and 5,586,970, the entire contents for eachof these patents being hereby incorporated herein by reference. In eachof these patents, adjustment of the condyle pad provides the wearer withthe ability to adjust the knee brace before or after it is in place toattempt to alleviate the discomfort from osteoarthritis. Each of thedevices disclosed in these patents is comprised of rigid and non-rigidcomponents that typically perform the desired functions. For thesepatents, however, adjustment of the condyle pad is the feature thatprovides relief to the wearer. This is accomplished in a variety ofways. For example, U.S. Pat. No. 4,372,298 discloses a knee brace havinga condyle pad on each side of the wearer's knee, each condyle pad beingadjustable via a living hinge 70 (see, e.g., FIG. 6) that is locatedapart from a rotation axes defined by upper and lower pivot pins 44, 48.Another example is found in U.S. Pat. No. 4,940,045, that discloses aknee guard and brace with an adjustable medial condyle support pad. Acondyle support pad 31 is secured to a plate 34 and connected to a rib23 with a hinge 41 (see, e.g., FIG. 4) located above the knee joint andspaced away from the condyle pad (see, e.g., FIG. 1). Adjustment of thecondyle pad is accomplished using a rotatable spacer 42 that includes aramp 43. As can be seen in FIGS. 3 and 4, rotation of the spacer 42causes displacement of the condyle support pad 31 towards and away fromthe wearer's knee. The pivot location of the hinge 41 and spacer 42 awayfrom the knee joint, and away from rotatable connection of the upper andlower ribs 23, 24 at pin 26 results in the creation of a significantvoid between the ribs 23, 24 and condyle support pad 31, as shown inFIG. 1. This results in a knee brace having a larger profile at the kneejoint, which may result in patients having to wear this brace outside oftheir clothing.

Yet another knee brace is disclosed in U.S. Pat. No. 5,586,970. The kneebrace disclosed in this patent comprises a main structural hinge 41 thatconnects upper and lower struts 10, 14 at a hinge axis 42. The kneebrace of this patent also has medial and lateral condyle pads 34, 36,each mounted to an upper strut 10 by a pivot pin 38 pivotable abouthorizontal pad axis 40. By providing a cam follower for each pivot pin38, and by offsetting the pivot pin 38 with respect to hinge 41, theknee brace disclosed in this patent provides for dynamic adjustment ofeach condylar pad 34, 36, approximating “the dynamically changing centerof pivot of the knee to hinge axis of main structural hinge 41.” Column5, lines 16-20. This is intended to provide a knee brace having acondyle pad that mimics the natural of movement of the knee joint, see,e.g., FIGS. 6-8. Each condyle pad is independently adjustable alonghorizontal pad axis 40, which is coaxial with pivot pin 38. See, e.g.,FIGS. 2 and 3. The '970 patent teaches that it is preferred that pivotpins 38 (and pivot axis 40) are offset with respect to the axis 42 ofthe brace's main structural hinge 41 from ⅞″ to 1⅜″ (see, e.g., column4, lines 51-54). This offset is provided to enable the knee brace totrack “the relative movement of the supracondylar hollow of the femurwith respect to the plateau of the fibula tibia.” Column 3, lines 34-38.Thus, the '970 patent teaches a knee brace with a rotational axis 42(corresponding to the brace's main structural hinge 41) that is offsetfrom a pivot pin 38 coaxial with a pivot axis 40 and along which eachcondyle pad is adjustable.

In each of the above-identified patents, knee braces are disclosedhaving an axis of rotation located proximate with the natural flexionpoint of the knee. The knee braces also include a pivot axis or pivotpoint for a condyle pad that is offset from the axis of rotation. Insome instances, such as with U.S. Pat. No. 5,586,970, separation of thepivot axis or pivot point from the axis of rotation is desired.Offsetting the pivot axis and rotation axis from each other typicallyresults in a knee brace defining an envelope that is significantlylarger than the wearer's knee (see, e.g., the '045 patent).Consequently, knee braces according to at least these prior artdocuments tend to take up a significant amount of space when worn,usually requiring that the brace be worn outside one's clothes.

Another prior art knee brace is disclosed in U.S. Pat. No. 5,302,169,the entire contents of which are incorporated herein. The '169 patentdiscloses a number of embodiments of a knee brace having rotation andpivot axes. It should be noted that what the '169 patent describes as apivot point is described in the present application as a rotation axis.It should also be noted that what the '169 patent refers to as a hingeis described in the present invention as a pivot axis. Thus, the pivotpoints disclosed in the '169 patent are at least similar in function tothe rotation axes of the present invention, and the hinge is at leastsimilar in function to the pivot axis of the present invention. In thiscontext, the '169 patent discloses a knee brace have two rotation axesdisclosed as pivot points defined by bolts 40 (see, e.g., FIG. 2), and apivot axis disclosed as a hinge 64. For each disclosed embodiment of the'169 patent, and using the terminology of the present invention, therotation axes are spatially separated from each other, as are the pivotaxes, and none of the foregoing intercept. In the embodiment of FIG. 4,a single pivot axis is disclosed as a hinge 64 between arms 18 and 22.In this embodiment, the rotation axes are spatially separated from eachother, and a single pivot axis (defined by hinge 64) is offset fromintersecting the rotation axes. In addition, the single pivot axis islocated at a location that is equidistant from the rotation axes,locating the pivot axis at a center point between the rotation axes, andapproximately a center point of the knee joint.

There thus exists a need for a knee brace that overcomes the foregoingand other shortcomings of the prior art.

SUMMARY OF THE INVENTION

Embodiments of the present invention provide a knee brace overcoming theabove-described and other shortcomings of the prior art.

The present invention is directed to an improved knee brace that hasmany advantages over the prior art. In accordance with embodiments ofthe present invention, a knee brace comprises a first cuff connectablewith an articulation assembly at a first location defining a first pivotaxis, and at a second location defining a first rotation axis.Preferably, the first rotation axis and first pivot axis intersect eachother. An embodiment of the present invention further comprises a secondcuff connectable with the articulation assembly at a third locationdefining a second pivot axis, and at a fourth location defining a secondrotation axis, the second pivot axis and second rotation axis preferablyintersecting each other. Alternatively, yet still preferably, the firstrotation axis is offset from intersecting the first pivot axis, and thesecond rotation axis is offset from intersecting the second pivot axis,with neither the first pivot axis nor the second pivot axis beinglocated at a location that is between and equidistant from the first andsecond rotation axes.

Alternatively, yet still preferably, a knee brace in accordance withembodiments of the present invention comprises a first cuff connectedwith an articulation assembly at a first location defining a first pivotaxis, wherein an angle of inclination between the articulation assemblyand the first cuff is adjustable, and wherein the brace defines anenvelope about the joint when on the wearer's extremity, wherein theenvelope does not increase with adjustment of the angle of inclination.This aspect of the present invention is possible, at least in part,because of the inventive positioning of the rotation and pivotaxes—preferably intersecting or offset from intersecting and withneither the first nor second pivot axis at a location that is betweenand equidistant from the first and second rotation axes.

There are a number of advantages of locating the rotation and pivot axesto intersect, or to be offset from intersecting in accordance withembodiments of the present invention. An objective of certain types ofknee braces is to relieve pain and discomfort of osteoarthritis. This istypically done by modifying the compartmental unloading of the kneejoint to change its biomechanics. The present invention achieves this bylocating both the pivot axis and rotation axis in relation to each otherto provide a maximum effect on changing the biomechanics of the kneejoint in a knee brace having a low profile when worn. A knee brace inaccordance with embodiments of the present invention thus provides foradjustability of the knee brace at or near where the change inbiomechanics should occur, i.e., at the knee joint. Advantageously, andpreferably, the present invention accomplishes this with intersectingpivot and rotation axes. Alternatively, yet still preferably, thepresent invention also accomplishes this by non-intersecting pivot androtation axes that are still relationally located to provide maximumbenefits to the wearer, and minimum profile for a knee brace.

Moreover, a knee brace in accordance with embodiments of the presentinvention provides both a pivot axis and a rotation axis that eitherintersect each other, or that are offset from intersecting yet notlocated at a location between and equidistant from the rotation axes,thereby providing adjustment means aligned with the natural anatomy ofthe leg and knee. The inventive knee brace thus conforms closely to thenatural anatomy of the knee. In contrast, prior art knee braces providefor adjustment means away from the center of the knee and fail to alignwith the natural anatomy of the leg.

A further advantage of a knee brace in accordance with embodiments ofthe present invention is a low-profile brace that minimally increases abrace envelope defined by the brace when it is in place on the wearer'sextremity. Prior art knee braces have significant variation in the braceenvelope because the size of the brace envelope changes significantly asthe brace is adjusted. This is due, at least in part, to the amount ofspace required with such braces to adjust the loading and unloading ofthe knee joint. As noted, prior art knee braces separate the rotationand pivot axes, locating the pivot axis (axes) away from the joint,resulting in a significant increase in the brace envelope when the braceis adjusted. Consequently, prior art knee braces are bulky, andtypically must be worn outside the wearer's clothes.

In accordance with embodiments of the present invention, at least one ofan upper cuff and a lower cuff is connected with an articulationassembly at rotation and pivot axes, with each pair (i.e., one pair forthe upper cuff, one pair for the lower cuff) of pivot and rotation axesbeing located in close proximity to each other, preferably intersecting.For example, the pivot axis for the upper cuff is in close proximity to,or intersects, the rotation axis for the upper cuff. This enablesadjustable, pivotable articulation of the knee brace at or near therotation axis, controlling pressure imparted to the knee from a condylepad located in contacting proximity to the knee. This ensures that thecondyle pad maintains contact with the knee, and that the upper andlower cuffs are always in intimate contact with parts of the wearer'sthigh and calf. As a result, embodiments of the present inventionprovide a low-profile knee brace. In a low-profile brace, the width ofthe knee and brace together (as viewed from the front), and the envelopof the joint area are minimized. Patients desire a low-profile bracebecause it can be worn beneath clothing, does not hinder them whilewalking (it does not bump into objects when walking), and has astreamlined appearance. In addition, research shows that a low-profileosteoarthritis brace increases patient compliance.

Research also shows that an easily patient adjustable osteoarthritisbrace increases patient comfort level. Different amounts of unloadingprovide different amounts of pain relief. Different amounts of braceadjustment provide different amounts of unloading. Different patientsrequire different amounts of pain relief/adjustment of the brace. Eventhe same patient requires different amounts of pain relief/adjustmentthroughout the day. An easily adjustable brace will encourage thepatient to adjust the brace and will therefore increase patient painrelief and comfort.

Other braces require tools to perform an adjustment—tools that may belost or that are not always readily available. When tools are notreadily available, the patient is discouraged from making an adjustmentand his/her pain level is not reduced.

A knee brace in accordance with embodiments of the present inventionemploys a mechanical advantage that enables the user to adjust the braceat any location at any time without the need for special tools ortraining. The mechanical advantage is provided by various parts of theinventive knee brace and make it easy to adjust the knee brace withoutsignificant effort, and without the need for tools or other assistance.If the mechanical advantage is not sufficient (such as for elderlypatients who may require a high degree of unloading of a joint),embodiments of the present invention include additional features andstructure to further enhance the mechanical advantage, such as, by wayof non-limiting example, slots to accept a coin or other similarly sizedand shaped disk-like object. Common currency coins are readily availablealmost everywhere there are people; using a coin, the user can employ anincreased mechanical advantage and adjust the brace at any location atany time. Thus, the present invention encourages the patient to adjustthe brace and will therefore increase his/her pain relief and comfort.

A brace that is adjusted to provide too much unloading applies excessiveforces to the leg, which can cause pain and discomfort. Typically, apatient may balance the pain relief from unloading against pain causedby an excessive adjustment. Other braces are adjustable only indiscrete, preset increments. This is a hindrance to a user whose painmanagement requires a setting between two available discreet increments.In accordance with embodiments of the present invention, a knee brace isprovided that is adjustable between the minimum and maximum levels ofunloading, as desired by the user or wearer, without preset, discrete,fixed settings. In addition, adjustment of the knee brace of the presentinvention is not limited to discrete, preset increments. Rather, theknee brace of the present invention is adjustable over an infinitenumber of settings between end points of the adjustment range. Thus, awearer can adjust the knee brace of the present invention for optimalcomfort, pain relief and unloading.

Embodiments of the present invention also include a visual indicator ofthe adjustment setting for the user's quick reference and guidance

Although the disclosure provided herein is directed primarily to a kneebrace for a human knee, it will be obvious to a person skilled in theart from such disclosure that the present invention is not limited tosuch an application. Rather, a knee brace in accordance with embodimentsof the present invention is usable on any joint of any animal.

An embodiment of the present invention is directed to a brace wearableon an extremity of a wearer, the extremity having a joint, and the bracecomprising a first cuff placeable on the extremity, an articulationassembly connected with the first cuff such that the first cuff ismovable with respect to the articulation assembly about a first locationdefining a first pivot axis between the first cuff and articulationassembly, and the first cuff is movable with respect to the articulationassembly about a second location defining a first rotation axis betweenthe first cuff and articulation assembly, wherein the first pivot axisand the first rotation axis intersect each other.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the articulation assemblyfurther comprises, a base, a mount connected to the base at the firstlocation, and connected to the first cuff at the second location, and anadjuster manipulable to cause the first cuff to pivot about the firstpivot axis.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the adjuster comprises, awedge movable along a surface of the mount to cause the first cuff topivot about the first pivot axis, a stud engaged with a part of thewedge such that manipulation of the stud causes movement of the wedgealong the surface of the mount, and a head manipulable to causemanipulation of the stud.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the first cuff furthercomprises a second part defining a first plane, and wherein the basedefines a second plane, and wherein the first rotation axis intersectsthe first plane at a fixed angle, and the second plane at a variableangle.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the variable angle isvariable by the adjuster.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the mount furthercomprises a boss, and wherein the articulation assembly furthercomprises a rotation pin connectable with the boss to connect the mountand the first cuff together at the second location.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the mount furthercomprises a tab, and wherein the articulation assembly further comprisesa pivot pin connectable with the tab to connect the mount and the firstcuff together at the first location.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the first cuff is movablewith respect to the articulation assembly in a first pivot directionabout the first location defining the first pivot axis between the firstcuff and articulation assembly, and wherein the first cuff is movablewith respect to the articulation assembly in a first rotation directionabout the second location defining the first rotation axis between thefirst cuff and articulation assembly.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the brace furthercomprises a second cuff placeable on the extremity, the articulationassembly being connected with the second cuff such that the second cuffis movable with respect to the articulation assembly about a thirdlocation defining a second pivot axis between the second cuff andarticulation assembly, and the second cuff is movable with respect tothe articulation assembly about a fourth location defining a secondrotation axis between the second cuff and articulation assembly, whereinthe second pivot axis and the second rotation axis intersect each other.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the second cuff is movablewith respect to the articulation assembly in a second pivot directionabout the third location defining the second pivot axis between thesecond cuff and articulation assembly, and wherein the second cuff ismovable with respect to the articulation assembly in a second rotationdirection about the fourth location defining the second rotation axisbetween the second cuff and articulation assembly.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the first cuff isrotatable about the first rotation axis, and the second cuff isrotatable about the second rotation axis, wherein the knee brace furthercomprises a gear having a first part defined on the first cuff, and asecond part defined on the second cuff, wherein the first part and thesecond part engage each other such that movement of one of the firstcuff and second cuff causes movement of the other one of the first cuffand second cuff.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the gear further comprisesfirst teeth on the first cuff, and second teeth on the second cuff,wherein the first teeth and the second teeth movably interlockinglyengage such that rotational movement of one of the first cuff and secondcuff causes corresponding rotational movement of the other one of thefirst cuff and second cuff.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein a surface on at least oneof the teeth of the first and second teeth is contoured.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the articulation assemblyfurther comprises a base, a first mount connected to the base at thefirst location, and connected to the first cuff at the second location,a second mount connected to the base at the third location, andconnected to the second cuff at the fourth location, and an adjustermanipulable to cause the first cuff to pivot about the first pivot axisand the second cuff to pivot about the second pivot axis.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the adjuster furthercomprises one of a head manipulable to cause the first cuff to pivotabout the first pivot axis and the second cuff to pivot about the secondpivot axis, or a first head and a second head, the first head beingmanipulable to cause the first cuff to pivot about the first pivot axis,and the second head manipulable to cause the second cuff to pivot aboutthe second pivot axis.

Another embodiment of the present invention is directed to a bracewearable on an extremity of a wearer, the extremity having a joint, thebrace comprising a first cuff placeable on the extremity, and anarticulation assembly connected with the first cuff at a first locationdefining a first pivot axis, wherein an angle of inclination between thearticulation assembly and the first cuff is adjustable, and wherein thebrace defines an envelope about the joint when on the wearer'sextremity, wherein the envelope does not increase with adjustment of theangle of inclination.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the brace furthercomprises a second cuff placeable on the extremity, the articulationassembly being connected with the second cuff at a third locationdefining a second pivot axis, and at a fourth location defining a secondrotation axis.

Another embodiment of the present invention is directed to a bracewearable on an extremity of a wearer, the extremity having a joint, thebrace comprising a first cuff placeable on a first part of theextremity, a second cuff placeable on a second part of the extremity,and an articulation assembly connected with the first cuff and thesecond cuff. The first cuff is movable with respect to the articulationassembly about a first location defining a first pivot axis between thefirst cuff and articulation assembly, and the first cuff is movable withrespect to the articulation assembly about a second location defining afirst rotation axis between the first cuff and articulation assembly.The second cuff is movable with respect to the articulation assemblyabout a third location defining a second pivot axis between the secondcuff and articulation assembly, and the second cuff is movable withrespect to the articulation assembly about a fourth location defining asecond rotation axis between the second cuff and articulation assembly,wherein the first pivot axis and the first rotation axis are offset fromintersecting each other, and wherein the second pivot axis and thesecond rotation axis are offset from intersecting each other, neither ofthe first pivot axis nor the second pivot axis being located at alocation that is between and equidistant from the first and secondrotation axes.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the first cuff is movablewith respect to the articulation assembly in a first pivot directionabout the first location defining the first pivot axis between the firstcuff and articulation assembly, and wherein the first cuff is movablewith respect to the articulation assembly in a first rotation directionabout the second location defining the first rotation axis between thefirst cuff and articulation assembly. Wherein the second cuff is movablewith respect to the articulation assembly in the second pivot directionabout the third location defining the second pivot axis between thesecond cuff and articulation assembly, and wherein the second cuff ismovable with respect to the articulation assembly in a second rotationdirection about the fourth location defining the second rotation axisbetween the second cuff and articulation assembly.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the articulation assemblyfurther comprises a base, a first mount connected to the base at thefirst location, and connected to the first cuff at the second location,a second mount connected to the base at the third location, andconnected to the second cuff at the fourth location, and an adjustermanipulable to cause at least one of the first cuff or the second cuffto pivot about the first pivot axis or the second pivot axes,respectively.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the adjuster comprises awedge movable along a surface of one of the first and second mount tocause one of the first cuff or second cuff to pivot about the firstpivot axis or second pivot axis, respectively, a stud engaged with apart of the wedge such that manipulation of the stud causes movement ofthe wedge along the surface of the one of the first or second mount, anda head manipulable to cause manipulation of the stud.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the articulation assemblyfurther comprises a base, and wherein the first cuff further comprises asecond part defining a first plane, and wherein the second cuff furthercomprises a second part defining a second plane, wherein the basedefines a third plane, and wherein the first rotation axis intersectsthe first plane at a fixed angle, and intersects the third plane at avariable angle, and wherein the second rotation axis intersects thesecond plane at a fixed angle, and intersects the third plane at avariable angle.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the articulation assemblyfurther comprises an adjuster, and wherein the variable angle isvariable by the adjuster.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the first and second mounteach further respectively comprise a first boss and a second boss, andwherein the articulation assembly further comprises a first rotation pinconnectable with first boss to connect the first mount and the firstcuff together at the second location, and a second rotation pinconnectable with the second boss to connect the second mount and thesecond cuff together at the fourth location.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the first and second mounteach further respectively comprise a first tab and a second tab, andwherein the articulation assembly further comprises a first pivot pinconnectable with the first tab to connect the first mount and the firstcuff together at the first location, and a second pivot pin connectablewith the second tab to connect the second mount and the second cufftogether at the third location.

Another embodiment of the present invention is directed to a bracewearable on an extremity of a wearer, brace wearable on an extremity ofa wearer, the extremity having a joint, the brace comprising a firstcuff placeable on the extremity, and an articulation assembly connectedwith the first cuff, wherein the first cuff is movable with respect tothe articulation assembly about a first location defining a first pivotaxis between the first cuff and articulation assembly, and wherein thefirst cuff is movable with respect to the articulation assembly about asecond location defining a first rotation axis between the first cuffand articulation assembly, wherein the first pivot axis and the firstrotation axis are offset from intersecting each other. The articulationassembly further comprises a base, a mount connected to the base at thefirst location, and connected to the first cuff at the second location,and an adjuster manipulable to cause the first cuff to pivot about thefirst pivot axis.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the first cuff is movablewith respect to the articulation assembly in a first pivot directionabout the first location defining the first pivot axis between the firstcuff and articulation assembly, and wherein the first cuff is movablewith respect to the articulation assembly in a first rotation directionabout the second location defining the first rotation axis between thefirst cuff and articulation assembly.

An embodiment of the present invention is further directed to a bracewearable on an extremity of a wearer, wherein the first pivot axis islocated at a location between the rotation axis and the joint.

DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention will now be described withreference to the following figures, wherein:

FIG. 1 depicts a front view of a knee brace for a right leg inaccordance with an embodiment of the present invention;

FIG. 2 depicts a right-side view of the knee brace of FIG. 1;

FIG. 3 depicts a right-side view of the knee brace of FIG. 1 in a flexedposition;

FIG. 4A depicts a view of an articulation assembly of a knee brace withboth upper and lower cuffs in accordance with an embodiment of thepresent invention;

FIG. 4B depicts a view of an articulation assembly of a knee brace withthe upper cuff removed;

FIG. 5 depicts a side view of an articulation assembly of a knee bracein accordance with an embodiment of the present invention;

FIGS. 6A and 6B respectively depict a pivot axis and a rotation axis ofa knee brace in accordance with an embodiment of the present invention;

FIG. 7 depicts a side view of an articulation assembly of a knee bracein accordance with an embodiment of the present invention showing afirst angular relationship between parts of the knee brace;

FIG. 8 depicts a side view of an articulation assembly of a knee bracein accordance with an embodiment of the present invention showing asecond angular relationship between parts of the knee brace;

FIG. 9 depicts a perspective side view of parts of an articulationassembly of a knee brace in accordance with an embodiment of the presentinvention;

FIG. 10 depicts a perspective view of an articulation assembly of a kneebrace in accordance with an embodiment of the present invention;

FIG. 11 depicts a rotation pin in accordance with embodiments of thepresent invention;

FIG. 12 depicts a detail view of the teeth of a gear in accordance withembodiments of the present invention;

FIG. 13 depicts a detail view of a mount in accordance with anembodiment of the present invention; and

FIG. 14 depicts a four-bar linkage useable as part of an articulationassembly in accordance with an embodiment of the present invention.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The following describes exemplary embodiments of the present invention.It should be apparent to those skilled in the art from the disclosureprovided herein that the described embodiments of the present inventionare illustrative and not limiting, having been presented by way ofexample only. All features disclosed in this description may be replacedby alternative features serving the same or similar purpose, unlessexpressly stated otherwise. Therefore, numerous and various otherembodiments are contemplated as falling within the scope and spirit ofthe present invention. In addition, embodiments of the present inventioncomprising similar features and structure may be described singularly(e.g., description of an upper cuff without a corresponding descriptionof a similar lower cuff). It will be obvious to persons skilled in theart, and from the disclosure provided herein, that such discussion anddescription of a first feature or structure is intended to, and doescover a second similar feature or structure, unless expressly disclosedto the contrary.

A knee brace 100 in accordance with embodiments of the present inventionis depicted in FIGS. 1, 2 and 3. The knee brace 100 depicted in thefigures and described herein is intended to be worn on the right leg ofa human and to unload the medial compartment of the knee. It will beobvious to a person of skill in the art that the disclosure of thepresent invention applies equally for a brace to be worn on the rightleg of a human to unload the lateral compartment of the knee, as well asto be worn on the left leg of a human, as well as a brace to be wornnear a joint of any animal. The knee brace 100 comprises an upper cuff110, a lower cuff 120, and an articulation assembly 200. The upper cuff110 is designed and configured to fit around a part of a wearer's thigh,and the lower cuff 120 is designed and configured to fit around a partof the wearer's calf. An upper sleeve 132 fits within and is secured tothe upper cuff 110, and a lower sleeve 134 fits within and is secured tothe lower cuff 120, each providing a comfortable fitting between thecuff 110, 120 and the part of the wearer's thigh and calf, respectively.Each of the upper and lower cuffs 110, 120 and/or sleeves 132, 134 mayhave one or more straps, connectors, fasteners, etc. (not shown) usableto adjust the fit of the cuff 110, 120 and/or sleeve 132, 134 around thepart of the wearer's thigh and calf, respectively.

The upper cuff 110 has a first part 112 that has a generally contouredshape complementary with the shape of a human thigh. The first part 112may be made from metal, carbon fiber, fiberglass, or other similarmaterial, as a routine matter of design choice, and may be covered witha material providing protective and/or aesthetic properties andcharacteristics. The upper cuff 110 further comprises a second part 114connected to or unitarily formed with the first part 112. The secondpart 114 extends from the first part 112 away from the wearer's thighand towards the wearer's knee. The second part 114 has a free end 136with a plurality of teeth 118 (see, e.g., FIG. 4A). It will be obviousto a person skilled in the art and based upon the disclosure providedherein that structure alternative to the disclosed teeth 118 may bedefined or provided at free end 136, provided that such alternativestructure performs the function(s) of the teeth 118 described herein.

The lower cuff 120 has a first part 122 that has a generally contouredshape complementary with the shape of a human calf. The first part 122may be made from metal, carbon fiber, fiberglass, or other similarmaterial, as a routine matter of design choice, and may be covered witha material providing protective and/or aesthetic properties andcharacteristics. The lower cuff 120 further comprises a second part 124connected to or unitarily formed with the first part 122. The secondpart 124 extends from the first part 122 away from the wearer's calf andtowards the wearer's knee. The second part 124 has a free end 138 with aplurality of teeth 128 (see, e.g., FIG. 4A). It will be obvious to aperson skilled in the art and based upon the disclosure provided hereinthat structure alternative to the disclosed teeth 128 may be defined orprovided in the free end 138, provided that such alternative structureperforms the function(s) of the teeth 128 described herein. The teeth118 of upper cuff 110 engage the teeth 128 of lower cuff 120 to form agear 170 so that movement of one of the upper cuff 110 and lower cuff120 causes movement of the other one, as shown in FIG. 3. It will beobvious to a person skilled in the art, and from the disclosure providedherein, that other structures are contemplated by, and with the scopeand spirit of the present invention for providing the functionality ofthe gear 170. The aforementioned description providing but oneembodiment. As noted, a knee brace 100 in accordance with embodiments ofthe present invention may comprise an upper cuff 110 and a lower cuff120 rotatingly engaged by a gear 170 comprised of teeth 118 on a freeend 136 of the upper cuff 110, and teeth 128 on a free end 138 of thelower cuff 120. In addition to each of the upper cuff 110 and lower cuff120 being rotatable about separate rotation axes, they are eachpivotable about separate pivot axes. They can thus simultaneously rotateand pivot about their respective axes. To ensure smooth rotation of eachof the upper and lower cuff 110, 120 during use, the design of the teeth118, 128 is important. As can be seen in FIG. 12, a surface 118 a, 128 aof a tooth is contoured with a compound radius wherein the surface isformed by two or more radii. Alternately a series of chamfers or othercuts may be used to achieve the same result. When at least one of theupper cuff 110 and lower cuff 120 is caused to move about its pivotaxis, the engagement between teeth 118, 128 will change, i.e., as theupper and lower cuffs 110, 120 are caused to pivot (or at least one iscaused to pivot) so too are the teeth 118, 128. Contoured surfaces 118a, 128 a enable the teeth 118, 128 to continue to move freely as thepivoted upper cuff 110 and/or lower cuff 120 are caused to rotate.Without the contoured surface 118 a, 128 a, the teeth 118, 128 wouldbind when one of the upper cuff 110 and lower cuff 120 pivots, therebypreventing rotation and rendering the knee brace inoperable. The presentinvention advantageously avoids such a situation with the contouredsurface 118 a, 128 a of the teeth 118, 128. A hinge spring 180 biasesfree ends 136, 138 of the second parts 114, 124 to maintain alignment ofthe teeth 118, 128, ensuring smooth rotational movement between theupper cuff 110 and lower cuff 120.

It will also be obvious to one skilled in the art that the intent of theinvention disclosed herein can be applied to other types of articulationassemblies, for example a four-bar linkage, as depicted in FIG. 14. Insuch a four-bar linkage, the base 210 and mounts 220 together would formone of the bars, each of the free ends 114, 124 would form a bar, and afourth bar would be formed from a separate, hinged component.

Referring next to FIGS. 4A, 4B, 5, 6A and 6B, the articulation assembly200 will now be described in detail. The articulation assembly 200comprises a base 210, a mount 220 (one for each upper and lower cuff110, 120) and an adjuster 230. The base 210 has a first side that facesthe wearer's knee when the knee brace 100 is in position on the wearer'sleg. A surface 214 of the first side is configured to receive a condylepad 202. The base 210 has a second side with a surface 212 that facesaway from the wearer's knee when the knee brace 100 is in position. Abase boss 226 extends from the surface 212 and is sized and shaped toreceive a pivot pin 222 for each of the upper cuff 110 and lower cuff120. The pivot pin 222 defines a pivot axis 154 for each of the uppercuff 110 and lower cuff 120 and connects each of them to the base 210via the mount 220.

As shown in FIG. 13, the mount 220 has a tab 208 having a generallyarcuate periphery 188 to facilitate pivoting of the upper cuff 110 andlower cuff 120 about their respective pivot axis 154. The arcuateperiphery 188 of the tab 208 of each mount 220 is positioned on or nearthe surface 212 of the base 210 when the mount 220 is connected to thebase 210 by the pivot pin 222. Each mount 220 also has a boss 228 toreceive a rotation pin 224 (see, e.g., FIG. 11) to connect each of theupper cuff 110 and lower cuff 120 to its respective mount 220 forrotation about the rotation axis 164. The boss 228 is preferablyinternally threaded to receive an externally threaded rotation pin 224that defines a rotation axis 164 for each of the upper cuff 110 andlower cuff 120. The rotation pin 224 may comprise a head section 216 anda stud section 218 having at least an external threaded partcomplementarily sized and shaped to be received by the internallythreaded boss 228. Alternatively, the stud section 218 may be internallythreaded and sized and shaped to receive an at least partiallyexternally threaded stud of the of the mount 220 (in place of the boss228).

Depicted in FIGS. 6A and 6B is the intersecting relationship between thepivot axes and rotation axes, in accordance with an embodiment of thepresent invention. Although only the pivot and rotation axes 154, 164 ofthe lower cuff 120 are shown in FIGS. 6A and 6B, the followingdescription applies as well to the pivot and rotation axes 154, 164 ofthe upper cuff 110. As discussed herein, the pivot axis 154 of each ofthe upper cuff 110 and lower cuff 120 is defined by the pivot pin 222connecting each upper and lower cuff 110, 120 to the articulationassembly 200 via a respective mount 220. The rotation axis 164 of eachof the upper cuff 110 and lower cuff 120 is defined by the rotation pin224 connecting each upper and lower cuff 110, 120 to the articulationassembly 200 via a respective mount 220. Preferably, the pivot axis androtation axis of the upper cuff 110 intersect, and the pivot axis androtation axis of the lower cuff 120 intersect, as depicted in FIGS. 6Aand 6B. Alternatively, the rotation axis 164 of at least one of theupper cuff 110 and lower cuff 120 may be offset from intersecting itscorresponding pivot axis 154. In a preferred embodiment, the axes areoffset from intersecting each other so that the pivot axis 154 islocated at a location between the rotation axes 164, preferably notbetween and equidistant from them.

In accordance with embodiments of the present invention, the size of theknee brace when in place on the wearer's extremity defines an envelopeabout the joint, referred to herein as the brace envelope, is minimizedbecause of the advantageous relational location of the rotation axes andpivot axes. Specifically, the intersecting relation between the axes, orthe offset from intersecting relation and location of the pivot axis ata location that is not between and equidistant from the first and secondrotation axes.

The articulation assembly 200 also comprises an adjuster 230 foradjusting the angular relationship of certain parts of the knee brace100, and correspondingly adjusting the effect the knee brace 100 has onthe biomechanics of the wearer's knee. In accordance with embodiments ofthe present invention, and as depicted at least in FIGS. 4A, 4B, 5 and9, the adjuster 230 comprises a head 236, studs 234 a, 234 b, and awedge 240. Although the wedge 240 is depicted in the figures as beinggenerally wedge-shape, it will be obvious to a person skilled in the artand from the disclosure provided herein that the wedge 240 of thepresent invention is not limited to such a shape. Rather, the wedge 240of the present invention may comprise a structure of any shape suitablefor causing pivotable movement of the upper cuff 110 and lower cuff 120about the pivot axis 154. Similarly, the head 236 depicted in thefigures as being generally tubular is not limited to such a shape, itbeing obvious to a person skilled in the art and from the disclosureprovided herein that other shapes are contemplated by, and within thescope and spirit of the present invention. The adjuster 230 provides amechanical advantage to the wearer resulting in simple and easyadjustment of the knee brace 100. The adjuster 230 enables adjustmentsto be made by hand or with ordinary objects such as a coin, i.e.,without the need for special tools. The head 236 preferably has atextured surface such as a knurled outer surface comprising a pluralityof generally longitudinal grooves 246. The head 236 also preferablycomprises a plurality of slots 248 that are sized and shaped to receivean adjustment tool such as, by way of non-limiting example, a coin orother similarly sized and shaped object. It will be obvious to a personskilled in the art that various other types and patterns may be used tocreate a knurled surface of the head 236 of the present invention. Athreaded stud 234 a, 234 b extends from each end of the head 236, eachstud 234 a, 234 b being rotatable with rotation of the head 236.Threaded studs 234 a, 234 b are threaded in opposite directions and eachengage a threaded through-hole in the wedge 240 such that rotation ofthe head 236 causes corresponding rotation of each 234 a, 234 b stud,and simultaneous movement of each wedge 240 towards and away from thehead 236. The wedge 240 defines a stop surface 242 to impede rotationalmovement of the upper cuff 110 and lower cuff 120 (as described in moredetail below), and to prevent hyperextension of the knee. Alternatelythe free end of the upper and lower cuffs may each include an extendingsurface that contact upon full extension of the leg/knee and preventhyperextension of the knee.

The wedge 240 also further comprises a ramp 244 that will causepivotable movement of the upper cuff 110 and lower cuff 120 about thepivot axis 154 based upon the position of the ramp 244. In accordancewith a preferred embodiment of the present invention, a user may adjustthe knee brace by rotating the head 236 of the adjuster 230, causingrotation of each of the threaded studs 234 a, 234 b and causing movementof the wedge 240 towards and away from the head 236, which results inmovement of the ramp 244. As can be seen in FIGS. 5, 7, and 8, the ramp244 is positioned to move along (any of contacting, non-contacting, orintermittently contacting) surface 212 towards and away from the pivotpin 222. As the ramp 244 is caused to move towards the pivot pin 222, itwill engage the mount 220, causing it to pivot about the pivot axis 154.This will cause a corresponding pivot of each of the upper cuff 110 andlower cuff 120 about its respective pivot axis 154. As the upper cuff110 and lower cuff 120 are generally fixed in place about the wearer'sthigh and calf, such movement of the ramp 244 and the correspondingpivot about the pivot axis 154 will result in a change in the angularrelationship between the cuffs 110, 120 and the base 210, also resultingin a change of pressure on the knee joint by the condyle pad 202.

In an alternative embodiment, separate heads 236 a, 236 b may beprovided for the upper cuff 110 and lower cuff 120 respectively. Eachhead 236 a, 236 b has a threaded stud 234 a, 234 b that threadedlyengages a threaded through hold in a wedge 240. In this embodiment, thepivot angle of the upper cuff 110 and lower cuff 120 can be separatelyadjusted using the separate heads 236 a, 236 b.

In a preferred embodiment, each of the upper cuff 110 and lower cuff 120can be caused to pivot about its respective pivot axis 154 by apredetermined amount. As can be seen in FIGS. 7 and 8, the second part114, 124 of each of the upper cuff 110 and lower cuff 120 respectivelyeach define a plane 196 a, 196 b, and the base 210 defines a plane 198.An angular relationship is defined between the planes 196 a, 196 b, and198 based upon the pivot of the upper cuff 110 and lower cuff 120 aboutthe pivot axis 154, which in turn is based upon the position of the ramp244. Because the rotation axis 164 is angularly fixed with respect tothe second part 114, 124, a fixed angular relationship exists betweenthe rotation axes 164 and planes 196 a, 196 b. However, an angularrelationship is also defined between the rotation axis 164 and plane198, and in a preferred embodiment, this angular relationship isvariable. Using the adjuster 230, a wearer can modify the biomechanicsof his/her knee by changing the angular relationship between planes 196a, 196 b, and 198. A first angular relationship is depicted in FIG. 7and designated as “A.” In this configuration, the condyle pad 202 willrest against the wearer's knee, applying a minimal amount of lateralpressure to the knee and minimally modifying the biomechanics of theknee. With the adjuster 230, the wearer may further modify thebiomechanics of his/her knee by causing the ramp 244 to move towards thepivot axis 154, causing each of the upper cuff 110 and lower cuff 120 topivot about their respective pivot axis 154, and changing the angularrelationship between planes 196 a, 196 b, and 198, designated as “B” inFIG. 8. In this configuration, the condyle pad 202 will exert greaterlateral pressure to the wearer's knee, resulting in a greatermodification of the biomechanics of that knee. The adjuster 230 thusenables the wearer to set the knee brace 100 for the desired support andcomfort.

Because of the construction of the upper cuff 110 and lower cuff 120,and the interconnection of the various parts of the knee brace 100 ofthe present invention, the amount of pressure imparted by the condylepad 202 on the wearer's knee is related to a number of factors. A firstone is the design and configuration of the upper and lower cuffs 110,120. Together with the upper and lower sleeves 132, 134, each isdesigned to snugly fit around a wearer's thigh and calf, and toremaining generally fixed in place while being worn. The interconnectionbetween the second part 114, 124 of each of the upper and lower cuffs110, 120 and the articulation assembly 200 also impacts the amount ofpressure applied by the condyle pad 202 to the knee. As discussedherein, a wearer can change the relationship of these parts and theirrespective interconnections using the adjuster 230 to modify the angularrelationship between the parts and impart more or less pressure to theknee joint. With the upper and lower cuffs 110, 120 essentially beingfixed in place on the wearer's thigh and calf, the adjuster 230 is usedto modify the amount of pressure imparted by the condyle pad 202 on thewearer's knee.

The complexity of the knee joint and its associated biomechanics aresomewhat simplified for discussion of the knee brace of the presentinvention. Similarly, the discussion of the inventive knee brace 100 maybe generalized at times for illustration purposes only. For example,discussion regarding pivotable movement about the pivot axis has been inthe context of movement of the upper and lower cuffs 110, 120,respectively about pivot axis 154. Such description may seem to requirethat the base 210 remain fixed in place to allow the cuff to pivot aboutthe pivot axis. However, it will be obvious to a person skilled in theart, in view of the disclosure provided herein, that neither the base210 nor the upper and lower cuffs 110, 120 are rigidly fixed in place,and the movement about the pivot axis 154 involves movement of both theupper and lower cuffs 110, 120, and the base 210 relative to each other.Thus, discussion herein regarding pivotable movement about the pivotaxis 154 is not dependent upon, nor limited to movement of any onemoveable structural component to any one fixed structure component.

Use of the present invention will now be discussed in greater detail,with continued reference to the drawings. The dimensions of the variousparts of the knee brace 100 of the present invention may be varied basedupon the height, weight, age, etc. of the wearer. The knee brace 100 mayalso be custom fitted to a specific wearer such that the contour of eachof the upper and lower cuff 110, 120 is custom sized and shaped, or theinventive knee brace may be provided in standard, predeterminedconfigurations, or as a one-size-fits-all. The upper and lower sleeves132, 134 are secured, respectively, to the upper and lower cuffs 110,120 in any manner that prevents the sleeves 132, 134 from beingdisplaced from their respective cuffs 110, 120. The sleeves 132, 134each include straps, connectors, clips, clasps, etc. necessary to securethe sleeve 132, 134 and corresponding cuff 110, 120 in place. Once theknee brace 100 is firmly in place on the wearer's leg, the brace 100should not significantly slide up or down when in use. The knee brace100 is positioned on the wearer's leg so that the condyle pad 202 islocated proximate with, and preferably in contact with a medial orlateral side of the wearer's knee. The adjuster 230 is initially set sothat the angle between planes 196 a, 196 b, and 198 is minimal, as isthe amount of lateral pressure imparted on the knee joint by the condylepad 202. The adjuster 230 with one head 236 or separate heads 236 a, 236b is then used by the wearer or another to adjust the amount of pressurefrom the condyle pad 202 by causing pivotable movement of the upper andlower cuffs 110, 120 about the pivot axis 154, resulting in impositionof greater or lesser force by the condyle pad 202 on the knee joint andmodification of the biomechanics of the knee. Such modification canresult in compartmental weight-bearing shift and relief of compartmentalpressure, discomfort and pain.

Various parts and surfaces of the knee brace 100 of the presentinvention contact each other. Such surfaces may be treated, coated, orotherwise modified to facilitate smooth, repetitive movement. Materialsused to treat, coat, or otherwise modify the various parts and surfacesmay include, by way of non-limiting example, Teflon®, lubricants sold byDicronite®, and other now know, or hereafter developed lubricatingmaterials.

It will be obvious to a person of ordinary skill in the art, from thedetailed disclosure provided herein, that the present invention is notlimited to the embodiments disclosed herein. The inventor has discoveredan improved knee brace by locating a pivot axis and rotation axis of asingle cuff and articulation assembly to intersect with each other, orto be offset from intersecting such that the pivot axis is still locatedin a preferred location to yield the improvements of the presentinvention, which include, but are not limited to, improved biomechanicalperformance and a smaller knee brace. In a knee brace with upper andlower cuffs, the pivot axis for each of the upper and lower cuffs isoffset from intersecting its corresponding rotation axis such thatneither pivot axis is located at a location that is between andequidistant from its respective rotation axis. The present invention isthus not limited in spirit nor scope to the embodiments disclosed andclaimed herein, but rather extends to all now known and hereafterdeveloped embodiments that comprise the inventive aspects disclosedherein.

Modifications to embodiments of the present invention are possiblewithout departing from the scope of the invention as defined by theaccompanying claims. Expressions such as “including,” “comprising,”“incorporating,” “consisting of,” “have,” “is,” used to describe andclaim the present invention are intended to be construed in anon-exclusive manner, namely allowing for articles, components orelements not explicitly described herein also to be present. Referenceto the singular is to be construed to relate to the plural, whereapplicable.

Although specific example embodiments have been described, it will beevident that various modifications and changes may be made to theseembodiments without departing from the broader scope of the inventivesubject matter described herein. Accordingly, the specification anddrawings are to be regarded in an illustrative rather than a restrictivesense. The accompanying drawings that form a part hereof, show by way ofillustration, and not of limitation, specific embodiments in which thesubject matter may be practiced. The embodiments illustrated aredescribed in sufficient detail to enable those skilled in the art topractice the teachings disclosed herein. Other embodiments may beutilized and derived therefrom, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. This description, therefore, is not to be taken in alimiting sense, and the scope of various embodiments is defined only bythe appended claims, along with the full range of equivalents to whichsuch claims are entitled.

What is claimed is:
 1. A brace wearable on an extremity of a wearer, theextremity having a joint, the brace comprising: a first cuff placeableon the extremity; and an articulation assembly connected with the firstcuff at a first location defining a first pivot axis, wherein an angleof inclination between the articulation assembly and the first cuff isadjustable, and wherein the brace defines an envelope about the jointwhen on the wearer's extremity, wherein the envelope does not increasewith adjustment of the angle of inclination.
 2. A brace according toclaim 1, further comprising a second cuff placeable on the extremity,the articulation assembly being connected with the second cuff at athird location defining a second pivot axis, and at a fourth locationdefining a second rotation axis.
 3. A brace wearable on an extremity ofa wearer, the extremity having a joint, the brace comprising: a firstcuff placeable on a first part of the extremity; a second cuff placeableon a second part of the extremity; and an articulation assemblyconnected with the first cuff, wherein the first cuff is movable withrespect to the articulation assembly about a first location defining afirst pivot axis between the first cuff and articulation assembly, andwherein the first cuff is movable with respect to the articulationassembly about a second location defining a first rotation axis betweenthe first cuff and articulation assembly, and wherein the second cuff ismovable with respect to the articulation assembly about a third locationdefining a second pivot axis between the second cuff and articulationassembly, and wherein the second cuff is movable with respect to thearticulation assembly about a fourth location defining a second rotationaxis between the second cuff and articulation assembly, wherein thefirst pivot axis and the first rotation axis are offset fromintersecting each other, and wherein the second pivot axis and thesecond rotation axis are offset from intersecting each other, neither ofthe first pivot axis nor the second pivot axis being located at alocation that is between and equidistant from the first and secondrotation axes.
 4. A brace according to claim 3, wherein the articulationassembly further comprises: a base; a first mount connected to the baseat the first location, and connected to the first cuff at the secondlocation; a second mount connected to the base at the third location,and connected to the second cuff at the fourth location; and an adjustermanipulable to cause at least one of the first cuff or the second cuffto pivot about the first pivot axis or the second pivot axes,respectively.
 5. A brace according to claim 4, wherein the adjustercomprises: a wedge movable along a surface of one of the first andsecond mount to cause one of the first cuff or second cuff to pivotabout the first pivot axis or second pivot axis, respectively; a studengaged with a part of the wedge such that manipulation of the studcauses movement of the wedge along the surface of the one of the firstor second mount; and a head manipulable to cause manipulation of thestud.
 6. A brace according to claim 3, wherein the articulation assemblyfurther comprises a base, and wherein the first cuff further comprises asecond part defining a first plane, and wherein the second cuff furthercomprises a second part defining a second plane, wherein the basedefines a third plane, and wherein the first rotation axis intersectsthe first plane at a fixed angle, and intersects the third plane at avariable angle, and wherein the second rotation axis intersects thesecond plane at a fixed angle, and intersects the third plane at avariable angle.
 7. A brace according to claim 6, wherein thearticulation assembly further comprises an adjuster, and wherein thevariable angle is variable by the adjuster.
 8. A brace according toclaim 4, wherein the first and second mount each further respectivelycomprise a first boss and a second boss, and wherein the articulationassembly further comprises a first rotation pin connectable with firstboss to connect the first mount and the first cuff together at thesecond location, and a second rotation pin connectable with the secondboss to connect the second mount and the second cuff together at thefourth location.
 9. A brace according to claim 4, wherein the first andsecond mount each further respectively comprise a first tab and a secondtab, and wherein the articulation assembly further comprises a firstpivot pin connectable with the first tab to connect the first mount andthe first cuff together at the first location, and a second pivot pinconnectable with the second tab to connect the second mount and thesecond cuff together at the third location.
 10. A brace wearable on anextremity of a wearer, the extremity having a joint, the bracecomprising: a first cuff placeable on the extremity; and an articulationassembly connected with the first cuff, wherein the first cuff ismovable with respect to the articulation assembly about a first locationdefining a first pivot axis between the first cuff and articulationassembly, and wherein the first cuff is movable with respect to thearticulation assembly about a second location defining a first rotationaxis between the first cuff and articulation assembly, wherein the firstpivot axis and the first rotation axis are offset from intersecting eachother; wherein the articulation assembly further comprises: a base; amount connected to the base at the first location, and connected to thefirst cuff at the second location; and an adjuster manipulable to causethe first cuff to pivot about the first pivot axis.
 11. A braceaccording to claim 10, wherein the first pivot axis is located at alocation between the rotation axis and the joint.
 12. A brace accordingto claim 3, wherein the first cuff is movable with respect to thearticulation assembly in a first pivot direction about the firstlocation defining the first pivot axis between the first cuff andarticulation assembly, and wherein the first cuff is movable withrespect to the articulation assembly in a first rotation direction aboutthe second location defining the first rotation axis between the firstcuff and articulation assembly, and wherein the second cuff is movablewith respect to the articulation assembly in the second pivot directionabout the third location defining the second pivot axis between thesecond cuff and articulation assembly, and wherein the second cuff ismovable with respect to the articulation assembly in a second rotationdirection about the fourth location defining the second rotation axisbetween the second cuff and articulation assembly.
 13. A brace accordingto claim 10, wherein the first cuff is movable with respect to thearticulation assembly in a first pivot direction about the firstlocation defining the first pivot axis between the first cuff andarticulation assembly, and wherein the first cuff is movable withrespect to the articulation assembly in a first rotation direction aboutthe second location defining the first rotation axis between the firstcuff and articulation assembly.